# K082582: Sentinel, Model SP-001

- Pathway: 510(k) (Traditional)
- Applicant: C-Rad Positioning AB
- Decided: Mar 30, 2009 after 203 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K981153 (1999). 3 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052682: Alignrt, Vision RT Limited (2006) Summary page 1.

## Most influential descendants
- K113276: Catalyst (2012), 2 descendants of its own
- K120668: Sentinel (2012), 1 descendant of its own
- K241937: Klarity SGRT System (ARSG-E1A, ARSG-E3A) (2025), 0 descendants of its own
- K200435: Catalyst+, Catalyst+ HD (2020), 0 descendants of its own
- K200600: Sentinel (2020), 0 descendants of its own

## Indications for use
The Sentinel system is intended for use in radiation therapy clinics to accurately position patients in a reproducible way, prior to treatment and to monitor the patient continuously during treatment. The system provides information about a patient's position and the adjustments required in order to position the patient as close as possible to a reference setup. During monitoring, the system reports deviations in the patient's position during treatment. The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostics departments.

Source page: https://510kreport.com/device/K082582
Methodology: https://510kreport.com/methodology